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A Multicenter,Open Label, Randomized Trial Evaluating the Duration of Infusion of Zoledronic Acid 4 mg IV in Multiple Myeloma Patients With Bone Metastases

Phase 4
18 Years
Not Enrolling
Multiple Myeloma

Thank you

Trial Information

A Multicenter,Open Label, Randomized Trial Evaluating the Duration of Infusion of Zoledronic Acid 4 mg IV in Multiple Myeloma Patients With Bone Metastases

Inclusion Criteria:

- Patients 18 years of age or older

- Confirmed diagnosis of Multiple Myeloma

- Stable renal function defined as two serum creatinine determinations of < 3 mg/dL

- Calculated creatinine clearance of greater than or equal to 30 mL/min

- ECOG Performance Status of 0 or 1

- Life expectancy of greater than or equal to 9 months

- If the patient is of child-bearing potential, a negative pregnancy test is required
at screening, while postmenopausal women must be amenorrheic for at least 12 months
to be considered of non-childbearing potential.

- Ability to comply with trial requirements and give informed consent.

Exclusion Criteria:

- IV Bisphosphonate therapy for more than 3 years.

- Patients with a diagnosis of amyloidosis.

- Known hypersensitivity to zoledronic acid or other bisphosphonates

- Pregnant patients or lactating patients.

- Women of childbearing potential not on a medically recognized form of contraception

- Patients with uncontrolled cardiovascular disease, hypertension, and Type 2 diabetes

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The Number of Participants With a Significant Increase in Serum Creatinine at 12 Months

Outcome Description:

The primary renal safety endpoint was the number of participants with a clinically relevant increase in serum creatinine at 12 months. Serum creatinine was determined prior to each zoledronic acid infusion for all Participants and was considered to be significantly increased if there was an increase of 0.5 mg/dL or more or a doubling of the baseline serum creatinine value.

Outcome Time Frame:

Baseline and 12 Months

Safety Issue:


Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Chair

Investigator Affiliation:

Novartis Pharmaceuticals


United States: Institutional Review Board

Study ID:




Start Date:

October 2004

Completion Date:

October 2007

Related Keywords:

  • Multiple Myeloma
  • Z-MAX, multiple myeloma, zoledronic acid, bone metastases
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Neoplasm Metastasis
  • Bone Neoplasms
  • Bone Marrow Diseases



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